Family-Based Weight Wellness Treatment Through Food is Medicine and Group Medical Visits in Pediatric and Adult Primary Care

Обзор

The proposed project aims to implement and evaluate a novel, family-based lifestyle medicine intervention integrating group Shared Medical Appointments (SMAs) for parents and adolescents with a twelve-month medically tailored groceries (MTG) and six-month culinary medicine Food is Medicine program. The intervention provides adolescent weight wellness treatment through a holistic, community engaged approach leveraging family connection, clinical care, and nutrition support. Monthly SMAs will include time for parents and adolescents to meet independently and conclude together. These visits will be co-led by physicians, dietitians, and health professionals. Parents will receive the Ardmore Institute's Full Plate Living program while adolescents receive Tufts Pediatrics Strong, Positive and Resilient Kids (SPARK) Weight Wellness program. The SMA format is reimbursable, fosters peer support, enhances patient-provider interaction, and allows efficient delivery of education and care. Each session will include nutrition and lifestyle education, review of individualized weight care plans, and proactive goal setting tailored to adults, adolescents, and families.

Вмешательства

• Поведенческое Culinary medicine classes
  Culinary Education - Kids Test Kitchen: In Cohort 2, as part of the SMA, families will participate in six cooking classes. The curriculum emphasizes hands-on cooking, nutrition literacy, and family engagement.
• Поведенческое Medically Tailored Groceries
  Medically Tailored Groceries (MTG): In Cohorts 2 and 3 families receive twelve months of MTG at $250 USD per month. Groceries are customized to clinical goals such as weight management, blood pressure control, and glycemic regulation.
• Поведенческое Shared Medical Appointments
  Shared Medical Appointments (SMAs): Families will attend monthly 60-90-minute group visits. The SMAs will include separate parent and adolescent classes, followed by joint activities. Parent sessions will be led by Dr. Kane using the Ardmore Full Plate Living curriculum. Adolescent sessions will be led by Drs. Mauney and Bushard using the SPARK Wellness Program. Each SMA will integrate nutrition education, behavioral health support, and goal setting tailored to the patient and family needs.

Первичные конечные точки

• Change in BMI z-score [Срок оценки: Baseline to 12 months]

Вторичные конечные точки (8)

• Change in absolute BMI and waist circumference [Срок оценки: Baseline to 12 months and 18 months (6-month post-program follow-up).]
• Laboratory measures (ALT) [Срок оценки: Baseline to 12 months]
• Laboratory measures (hemoglobin A1C) [Срок оценки: Baseline to 12 months]
• Laboratory measures (lipid panel) [Срок оценки: Baseline to 12 months]
• Change in physical activity [Срок оценки: Baseline to 12 months]
• Change in media use [Срок оценки: Baseline to 12 months]
• Change in sleep [Срок оценки: Baseline to 12 months]
• Change in health-related quality of life [Срок оценки: Baseline to 12 months]

Критерии участия

Критерии включения

For children:

• Child aged 12-17 years at time of enrollment (inclusive)
• BMI ≥ 95% for age and sex based on CDC growth charts
• Comfortable speaking and reading English (due to limitations in intervention materials and qualitative data collection tools)
• Child is an active patient at Tufts Medical Center
• Child can provide assent, Willing and able to participate in the 18-month study, including attendance at scheduled in-person or telehealth sessions
• Access to a device with internet capability (e.g., computer, tablet, or smartphone) to engage with online intervention

For parents or guardians:

• Age 18+ at time of enrollment
• Primary caregiver is the legal guardian of the child
• Comfortable speaking and reading English (due to limitations in intervention materials and qualitative data collection tools)
• Can provide consent, Willing and able to participate in the 12-month study, including attendance at scheduled in-person or telehealth sessions
• Access to a device with internet capability (e.g., computer, tablet, or smartphone) to engage with online intervention components.

Критерии исключения

For Children:

• Participation is medically or developmentally inappropriate, including but not limited to: Severe intellectual disability or cognitive impairment preventing meaningful participation, Active eating disorder diagnosis or concerning disordered eating behaviors, Severe physical limitations or mobility impairments that would limit participation in lifestyle activities, Active unmanaged psychiatric condition (e.g., acute suicidality or psychosis) that may interfere with participation or consent
• Planned bariatric surgery or other weight loss procedures during the 12-month study period
• Child is currently pregnant or plans to become so in the next 12 months
• Plans to relocate or transfer care away from the participating clinic during the 12-month study period
• Concurrent participation in another weight management clinical trial that could confound results or interfere with study activities
• Parent is unwilling or unable to participate in the study
• Child is a parent (has their own child), is in the armed forces, or lives independently and manages their own affairs (emancipated)
• Child is a foster child, in state custody, or has an open DCF case pending as identified in the electronic medical record or disclosed verbally by child or guardian.

For parent:

• Severe intellectual disability or cognitive impairment preventing meaningful participation
• Plans to relocate or transfer care away from the participating clinic during the 12-month study period
• Unwilling or unable to participate in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Tufts Medical Center — Boston
• Tufts University — Boston

Идентификаторы

NCT: NCT07717658 · STUDY00006548 · 1267-Spring 2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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